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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Nelson Vergel is Seeking Input: Tell the FDA to Stop Attacking Compounded Hormones
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<blockquote data-quote="testiculus" data-source="post: 259119" data-attributes="member: 17128"><p>I wondered what the impact of being categorized in one of these categories is, so I looked up the regulations. The net of it is as follows:</p><p></p><p>Category 1: Not on the approved list, but the FDA won't take any enforcement actions if they are compounded. FDA is evaluating and may one day add to the approved list.</p><p>Category 2 & 3: Cannot be compounded, unless it is an FDA approved drug and is on the FDA drug shortage list.</p><p></p><p>This is effectively a ban on ibutamoren from compounding pharmacies. Doesn't look like there is any end in sight for the FDA's war against compounding pharmacies. I guess they figure it's better for everybody to get things from the black market rather than being under the care of a physician and a well run pharmacy.</p></blockquote><p></p>
[QUOTE="testiculus, post: 259119, member: 17128"] I wondered what the impact of being categorized in one of these categories is, so I looked up the regulations. The net of it is as follows: Category 1: Not on the approved list, but the FDA won't take any enforcement actions if they are compounded. FDA is evaluating and may one day add to the approved list. Category 2 & 3: Cannot be compounded, unless it is an FDA approved drug and is on the FDA drug shortage list. This is effectively a ban on ibutamoren from compounding pharmacies. Doesn't look like there is any end in sight for the FDA's war against compounding pharmacies. I guess they figure it's better for everybody to get things from the black market rather than being under the care of a physician and a well run pharmacy. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Nelson Vergel is Seeking Input: Tell the FDA to Stop Attacking Compounded Hormones
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